Predicate Device

Predicate Device

The term predicate device typically refers to a medical device that is similar to another device already legally marketed after 510k clearance in the United States. When a new medical device is being considered for approval or clearance by the FDA, it may undergo a process known as the 510(k) clearance process.

 

A medical device legally marketed in the US and can be used as a point of comparison to prove the performance and safety of the medical device that is seeking marketing clearance from the FDA is known as a predicate medical device. This product details of a predicate device, if proven to be substantially equivalent, can be used to demonstrate the effectiveness and safety of the medical device seeking clearance.

 

The use of split predicates is not encouraged by FDA. The reviewer must be able to verify the substantial equivalence to one predicate medical device. Multiple predicate devices can be used as long as they have the same intended use as the device seeking 510k clearance.

 

Conclusion: The use of a predicate device in the 510(k) process helps streamline the 510k application by leveraging existing knowledge about similar devices already on the market. However, it’s important to note that substantial equivalence does not necessarily mean identical to that of the device in question, there can be differences between the device in scope and the predicate device in design, materials, or other features.

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